BioBusiness

Crystalys Therapeutics CEO Dr James Mackay explains at BIO 2026 that gout remains an underserved therapeutic are and represents a compelling drug development target due to its unmet need and simple biology.

At BIO International Convention 2026, Sabeen Mekan, MD, of Zymeworks discussed how novel payloads, pathway-targeted ADCs, and multispecific antibody technologies are helping shape the next generation of antibody-drug conjugates for cancer treatment.

Jeff Talbot of Roseman University of Health Sciences discusses how Las Vegas is positioning itself as a growing life sciences hub by offering cost-effective laboratory space, access to capital, and a flexible environment for biotech startups and emerging companies.

MilliporeSigma's Sebastian Arana identifies process characterization gaps, tech transfer complexity, and analytical lag as top CGT manufacturing scale-up barriers at BIO 2026.

At BIO International Convention 2026, Mohit Trikha, PhD, CEO of Kiva Bioscience, discussed why emerging human-based preclinical models may have their greatest impact in predicting drug toxicity and tolerability rather than replacing animal testing outright.

The FDA's approval of sacituzumab govitecan-hziy for first-line metastatic triple-negative breast cancer validates the Trop-2/SN-38 hydrolyzable linker platform across four positive Phase 3 trials, with implications for ADC development strategy, pharmacogenomic labeling, and biomarker-stratified regulatory programs.

AbbVie has entered a definitive agreement to acquire Apogee Therapeutics for $10.9 billion, adding zumilokibart, a subcutaneous half-life extended IL-13 monoclonal antibody in Phase 3 development for atopic dermatitis, asthma, and eosinophilic esophagitis.

The deal, announced at BIO 2026, carries total potential value exceeding $2.5 billion and will use Insilico's Pharma.AI platform to drive target-to-candidate discovery across neuroinflammatory, neurodegenerative, and rare neurological indications.

Takeda will use Boltz biomolecular AI models to support structure prediction, affinity estimation, and molecular design in preclinical research.

The FDA has accepted Roche's supplemental BLA for a chemotherapy-free combination of mosunetuzumab (Lunsumio VELO) and polatuzumab vedotin (Polivy) in adults with relapsed or refractory large B-cell lymphoma, based on Phase 3 SUNMO trial data showing a 59% reduction in the risk of disease progression or death compared to standard salvage chemotherapy.

The supplemental approval is based on immunogenicity data from the STRIDE-13 phase 3 trial and, according to Merck, makes the vaccine the only one of its type specifically indicated for this at-risk pediatric population in the United States.

The company reported that phase I data show approximately 40% of patients remained cancer-free at 10 years, while 2 phase 2 trials are ongoing.

Cytiva’s Pierre-Alain Ruffieux discusses standardization, regionalization, talent gaps, and regulatory pathways shaping advanced biomanufacturing’s future ahead of BIO 2026.

The company reported that all three participants in the 3 µg/kg dose cohort achieved a ≥25% SALT score reduction following single-dose subcutaneous administration, with dose escalation ongoing toward a recommended phase 2 dose.

Johnson & Johnson reported that the MonumenTAL-3 trial showed 24-month progression-free survival up to 81.3% and overall survival up to 89.2% with the GPRC5D bispecific combination versus standard of care.

Novartis announced that delpacibart braxlosiran met primary and key secondary biomarker endpoints in the Phase 1/2 FORTITUDE study for facioscapulohumeral muscular dystrophy. The investigational antibody oligonucleotide conjugate is being evaluated as a potential disease-modifying therapy for a condition that currently has no approved treatments.

Gan & Lee has reported positive topline trial results for insulin ludefen in type 2 diabetes and the GLP-1 bofanglutide in obesity.

Phase 3 cancer vaccines and rare disease programs are positioning mRNA therapeutics beyond COVID-19, expanding precision treatment opportunities across oncology and genetic disorders.

Immunome has dosed the first patient in a Phase 1 clinical trial evaluating IM-1617, a potential first-in-class antibody-drug conjugate incorporating the company's proprietary HC74 topoisomerase I inhibitor payload. The study will assess safety and preliminary anti-tumor activity in patients with advanced solid tumors.

FDA has approved Organon's tocilizumab-bavi (Tofidence) for CAR T-cell–induced CRS and hospitalized COVID-19 in adults and children aged 2 years or older.

According to Eli Lilly and Company, the extended dosing interval reduces maintenance injections to as few as 6 per year without required topical corticosteroids.

Phase 3 data from Boehringer Ingelheim’s SYNCHRONIZE-1 and SYNCHRONIZE-MASLD trials meet their primary endpoints, with glucagon/GLP-1 dual agonism showing targeted metabolic fat reduction beyond body weight loss at 76 and 48 weeks.

The approval is based on phase 3 non-inferiority data from the IRAKLIA study, making isatuximab the first anticancer therapy administered via an on-body injector in the EU.

AI-driven protein design, continuous-learning R&D platforms, mechanistic PK/PD modeling, and automated analytical workflows are now foundational tools reshaping how biopharmaceuticals are discovered, characterized, and delivered.

Made Scientific and Pluristyx will integrate iPSC starting materials with CDMO services for cell therapy development.